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nimesulide + paracetamol Tablets 100 mg + 500 mg, 100 mg + 325 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
India
Manufacturer #21247

This CTD dossier owner and manufacturer is a leading pharmaceutical manufacturer in India, with production facilities in South Asia. They are known for producing high-quality generic medications across a range of therapy areas including antibiotics, analgesics, cough remedies, gastrointestinal treatments, and immune boosters. They offer various dosage forms such as tablets, capsules, liquids, powders, ointments, creams, ear drops, and enemas. The company holds several GMP certifications and has received numerous awards for quality, productivity, and ethical business practices from both national and international bodies. They are committed to making medicines affordable and accessible throughout the country.

Nimesulide

Nimesulide is a nonsteroidal anti-inflammatory drug which can reduce pain and reduce fever. Its has been found effective in the treatment of acute pains, of symptomatic treatment of osteoarthritis, and in primary dysmenorrhoea in adolescents and adults. Nimesulide’s mode of action is multifactorial and has a fast onset of action. Its actions block the production of prostaglandins, a chemical associated with pain, thereby relieving pain and inflammation. It is also used for period pains. it is not recommended for long-term use in the treatment of chronic conditions such as arthritis because of the increased risk of liver toxicity, including liver failure. Nimesulide’s brand names vary a great deal around the world, for example, the most prominent brands in Italy is called Nimesulene. Nimesulide was first launched in Italy as Aulin and Mesulid in 1985 and is available in more than 50 countries worldwide, including among others France, Portugal, Greece, Switzerland, Belgium, Russia, Thailand, and Brazil. Nimesulide has never been filed for FDA evaluation in the United States, where it is not marketed.

Forms and Dosage

Nimesulide is sold in a variety of forms including tablets, powder for dissolution in water, suppositories, mouth dissolving tablets, and topical gels. Nimesulide gets absorbed rapidly after oral administration. The normal recommended dost for adults and adolescents over 12 years of age is 100mg twice a day.

The cost of Nimesulide

This medicine is manufactured and sold by an wide range of companies, manufacturers and labelers. It is sold as a generic medication in India and in many other countries and tends to be inexpensive. The retail price of tablet can range from 1 cent to 50 cents based on the brands being bought.

How does Nimesulide work?

Nimesulide starts working rapidly, with meaningful reductions in pain and inflammation within 15 minutes observed. its effects are the result of its complex mode of action, which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes, and histamine. Clinical evidence is available to support a particularly good profile in terms of gastrointestinal tolerability.

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